Pediatric CancersNCT00477256
School Reintegration Outcomes in Pediatric Cancer Patients
An observational study of Pediatric Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To examine illness-related factors (i.e., severity of illness, quality of life rating) as predictors or correlates of child adjustment to pediatric cancer. 2. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Cancers
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children between 6 and 17 years diagnosed with, and treated for, any type of cancer, their parent(s) or caregiver(s), and medical staff (i.e., physicians, nurse practitioners) involved in the children's medical decision-making.
Who may be able to join
- Children between 6 and 17 years diagnosed with, and treated for, any type of cancer
- Children enrolled in grades K through 12
- Children who have actively participated in community or private school during the 2006-2007 academic year
- Children who have experienced a period of absence from community or private school of at least two consecutive months as a result of medical treatment prior to school reintegration
- Children who have fully reintegrated as a full-time student within the past 1-3 years
- Parents and children who are either English- or Spanish-speaking and are able to read in either or both languages
- Medical staff (i.e., physicians, nurse practitioners) involved in the children's medical decision-making
Who cannot join
- Children and/or parents diagnosed and/or identified as having mental retardation (IQ < 70) with concomitant adaptive behavior deficits or classified as having any type of Pervasive Developmental Disorder (PDD)
- Children and/or parents who speak a language other than English or Spanish
- Participant (e.g., parent or child) unwillingness to participate in any capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychosocial Predictors of Child Adjustment and School Reintegration Outcome in a Pediatric Cancer Population
Primary Objectives:
- To examine illness-related factors (i.e., severity of illness, quality of life rating) as predictors or correlates of child adjustment to pediatric cancer.
- To examine illness-related factors (i.e., severity of illness, quality of life rating) as predictors of school reintegration (i.e., school attendance) in children with pediatric cancer.
- To examine a within-parent factor (i.e., parental stress) as a predictor or correlate of child adjustment to pediatric cancer.
- To examine a within-parent factor (i.e., parental stress) as a predictor or correlate of school reintegration (i.e., school attendance).
Read more
Secondary Objectives:
- To examine a second within-parent factor (i.e., parental perception of child vulnerability) as a predictor or correlate of child adjustment to pediatric cancer.
- To examine a second within-parent factor (i.e., parental perception of child vulnerability) as a predictor or correlate of school reintegration (i.e., school attendance) in children with pediatric cancer.
- To develop a statistical model by which relative contributions of each predictor variable (i.e., severity of illness, quality of life, parental stress, parental perception of child vulnerability), as well as their interrelatedness, can be understood in relation to child adjustment. Exploration of each variable's contribution will affect the schematic organization of the model.
- To examine demographic variables as covariates in the primary analyses. The variables include: child's age, gender, grade, ethnicity, diagnosis, time since diagnosis, type and duration of treatment, and time since school reintegration.
Read the detailed description
Consent for Child Participation:
STUDY PARTICIPATION:
If you agree to take part in this study, you will complete 3 paper-and-pencil questionnaires that will be used to get information about your health status and overall well being. You will be asked how you are feeling at this time, whether you worry a lot of the time, how often you feel sad, and how physically active you are, such as with walking and running. The study staff is also interested in knowing how well you are keeping up with school activities and how often you attend school. Finally, your doctor will provide information about your illness and describe how it may affect your participation at home or at school.
If you are age 8 or above, it should take about 30-45 minutes to complete the questionnaires. If you are between age 6 and 7, it should take about 10-15 minutes to complete the questionnaires.
Your parent or caregiver may be present while you complete your questionnaires. However, you are encouraged you to give your own answers. The questionnaires may be completed in The Children's Cancer Hospital clinic or elsewhere, and a research assistant will assist you, if you need help.
Length of Study:
Your participation in this study will be over once you have completed the 3 questionnaires.
This is an investigational study. Up to 106 children will take part in this study. All will be enrolled at M. D. Anderson.
Consent for Medical Staff Participants:
Child Adjustment to Pediatric Cancer and School Reintegration:
Researchers want to examine illness-related factors (such as severity of illness and quality of life) as predictors or correlates of adjustment to pediatric cancer and predictors of school reintegration (such as school attendance) of children with pediatric cancer.
Study Participation:
If you agree to take part in this study, you will complete one, 7-item paper-and-pencil measure that will be used to obtain information about your patient's current health status. For example, the first question asks, "On a Likert scale of 1 to 7, describe the degree of impairment for this child." One (1) indicates "Independent functioning, requires no assistance," and 7 indicates "Requires complete assistance." It should take about 2-5 minutes to complete the measure in the clinic or your office, and it can be done during regular work hours.
You will also be asked to describe information on the child's severity of illness. For example, you will be asked to describe the degree of impairment, frequency of medical procedures/hospitalizations, and your understanding of the child's participation in community activities.
Length of Study:
Your participation in this study will be over once you have completed the measure. Study results will be published and mailed to each medical staff participant.
This is an investigational study. Up to 24 medical staff members will take part in this study. All will be enrolled in this study at M. D. Anderson.
Consent for Parent or Caregiver Participation:
Child Adjustment to Pediatric Cancer and School Reintegration:
Researchers want to learn about illness-related factors (such as severity of illness and quality of life) that may show how well children with cancer adjust to the disease and return to a traditional school setting (by looking at school attendance, for example).
Your Study Participation:
If you agree to take part in this study, you will complete 5 paper-and-pencil questionnaires that will be used to get information about you and your child's health status. Questions will be about your child's physical, emotional, and social functioning as well as how they are functioning in school. You will be asked to rate how much of a problem you think your child may be having in these areas. You will also be asked about how often difficult events have occurred for you as a parent or caregiver of a child with cancer. These questionnaires should take about 45 minutes to 1 hour to complete.
The Child's Participation:
Your child will also be asked to complete 3 paper-and-pencil questionnaires that will also be used to get information about his or her health status, as well as his or her overall well being.
You may be present with your child while he or she is completing the questionnaires, if you choose. However, you are encouraged to allow the child to complete the questionnaires on his or her own so as not to influence the child's answers. A research assistant will be glad to assist your child with his or her completion of the questionnaires.
Location for Completion of Questionnaires:
The questionnaires for both you and the child may be completed in a private consultation room or examination room in The Children's Cancer Hospital clinic, or they may be completed outside of the room or clinic and returned to study staff.
If they are completed outside of the room or clinic, you can hand deliver the questionnaires to the clinic in an envelope, or you can mail them back to study staff in a postage-paid return envelope that can be provided to you.
Length of Study:
Your participation in this study will be over once you have completed the 5 questionnaires. You may receive a summary of the study's findings at the end of the study if you make this request to the study researcher who gave the questionnaires to the study doctor.
This is an investigational study. Up to 106 parents or caregivers will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Pediatric Cancers
- Being tested
- Questionnaires
- Keywords
- Pediatric Cancer, Child Adjustment, School Reintegration, Caregiver, Questionnaire, Quality of Life, Survey
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Survey
5 Paper-and-Pencil Questionnaires: All participants will engage in a one-time completion of all measures.
| Study group | Role | What they receive |
|---|---|---|
| Child | Children between 6 and 17 years diagnosed with, and treated for, any type of cancer. Receives: Behavioral: Questionnaires | |
| Parent | Parent(s) or caregiver(s) of children with cancer. Receives: Behavioral: Questionnaires | |
| Medical Staff | Medical staff (i.e., physicians, nurse practitioners) involved in the children's medical decision-making. Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Illness [using The Severity of Illness Scale (SOIS)]
Measured: Completion of scale by medical staff, approximately 2-5 minutes
Quality of Life [using The Pediatric Quality of Life (PedsQL)]
Measured: Questionnaire, approximately 45 minutes to one hour for parent or non-parent caregivers to complete their measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2007 (estimated)
- Study startMay 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha Askins, PhD, BA, MA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477256
- Sponsor's protocol ID
- 2007-0007
- Status last verified
- Jul 2012
- First submitted
- 22 May 2007
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Predictors of Child Adjustment and School Reintegration Outcome in a Pediatric Cancer Population
- ClinicalTrials.gov ID
- NCT00477256
- Acronym / sponsor ID
- 2007-0007
- Conditions
- Pediatric Cancers
- Keywords
- Pediatric Cancer, Child Adjustment, School Reintegration, Caregiver, Questionnaire, Quality of Life, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 23 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- To examine illness-related factors (i.e., severity of illness, quality of life rating) as predictors or correlates of child adjustment to pediatric cancer.
- To examine illness-related factors (i.e., severity of illness, quality of life rating) as predictors of school reintegration (i.e., school attendance) in children with pediatric cancer.
- To examine a within-parent factor (i.e., parental stress) as a predictor or correlate of child adjustment to pediatric cancer.
- To examine a within-parent factor (i.e., parental stress) as a predictor or correlate of school reintegration (i.e., school attendance).
Secondary Objectives:
- To examine a second within-parent factor (i.e., parental perception of child vulnerability) as a predictor or correlate of child adjustment to pediatric cancer.
- To examine a second within-parent factor (i.e., parental perception of child vulnerability) as a predictor or correlate of school reintegration (i.e., school attendance) in children with pediatric cancer.
- To develop a statistical model by which relative contributions of each predictor variable (i.e., severity of illness, quality of life, parental stress, parental perception of child vulnerability), as well as their interrelatedness, can be understood in relation to child adjustment. Exploration of each variable's contribution will affect the schematic organization of the model.
- To examine demographic variables as covariates in the primary analyses. The variables include: child's age, gender, grade, ethnicity, diagnosis, time since diagnosis, type and duration of treatment, and time since school reintegration.
Detailed description
Consent for Child Participation:
STUDY PARTICIPATION:
If you agree to take part in this study, you will complete 3 paper-and-pencil questionnaires that will be used to get information about your health status and overall well being. You will be asked how you are feeling at this time, whether you worry a lot of the time, how often you feel sad, and how physically active you are, such as with walking and running. The study staff is also interested in knowing how well you are keeping up with school activities and how often you attend school. Finally, your doctor will provide information about your illness and describe how it may affect your participation at home or at school.
If you are age 8 or above, it should take about 30-45 minutes to complete the questionnaires. If you are between age 6 and 7, it should take about 10-15 minutes to complete the questionnaires.
Your parent or caregiver may be present while you complete your questionnaires. However, you are encouraged you to give your own answers. The questionnaires may be completed in The Children's Cancer Hospital clinic or elsewhere, and a research assistant will assist you, if you need help.
Length of Study:
Your participation in this study will be over once you have completed the 3 questionnaires.
This is an investigational study. Up to 106 children will take part in this study. All will be enrolled at M. D. Anderson.
Consent for Medical Staff Participants:
Child Adjustment to Pediatric Cancer and School Reintegration:
Researchers want to examine illness-related factors (such as severity of illness and quality of life) as predictors or correlates of adjustment to pediatric cancer and predictors of school reintegration (such as school attendance) of children with pediatric cancer.
Study Participation:
If you agree to take part in this study, you will complete one, 7-item paper-and-pencil measure that will be used to obtain information about your patient's current health status. For example, the first question asks, "On a Likert scale of 1 to 7, describe the degree of impairment for this child." One (1) indicates "Independent functioning, requires no assistance," and 7 indicates "Requires complete assistance." It should take about 2-5 minutes to complete the measure in the clinic or your office, and it can be done during regular work hours.
You will also be asked to describe information on the child's severity of illness. For example, you will be asked to describe the degree of impairment, frequency of medical procedures/hospitalizations, and your understanding of the child's participation in community activities.
Length of Study:
Your participation in this study will be over once you have completed the measure. Study results will be published and mailed to each medical staff participant.
This is an investigational study. Up to 24 medical staff members will take part in this study. All will be enrolled in this study at M. D. Anderson.
Consent for Parent or Caregiver Participation:
Child Adjustment to Pediatric Cancer and School Reintegration:
Researchers want to learn about illness-related factors (such as severity of illness and quality of life) that may show how well children with cancer adjust to the disease and return to a traditional school setting (by looking at school attendance, for example).
Your Study Participation:
If you agree to take part in this study, you will complete 5 paper-and-pencil questionnaires that will be used to get information about you and your child's health status. Questions will be about your child's physical, emotional, and social functioning as well as how they are functioning in school. You will be asked to rate how much of a problem you think your child may be having in these areas. You will also be asked about how often difficult events have occurred for you as a parent or caregiver of a child with cancer. These questionnaires should take about 45 minutes to 1 hour to complete.
The Child's Participation:
Your child will also be asked to complete 3 paper-and-pencil questionnaires that will also be used to get information about his or her health status, as well as his or her overall well being.
You may be present with your child while he or she is completing the questionnaires, if you choose. However, you are encouraged to allow the child to complete the questionnaires on his or her own so as not to influence the child's answers. A research assistant will be glad to assist your child with his or her completion of the questionnaires.
Location for Completion of Questionnaires:
The questionnaires for both you and the child may be completed in a private consultation room or examination room in The Children's Cancer Hospital clinic, or they may be completed outside of the room or clinic and returned to study staff.
If they are completed outside of the room or clinic, you can hand deliver the questionnaires to the clinic in an envelope, or you can mail them back to study staff in a postage-paid return envelope that can be provided to you.
Length of Study:
Your participation in this study will be over once you have completed the 5 questionnaires. You may receive a summary of the study's findings at the end of the study if you make this request to the study researcher who gave the questionnaires to the study doctor.
This is an investigational study. Up to 106 parents or caregivers will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Child | – | Behavioral: QuestionnairesChildren between 6 and 17 years diagnosed with, and treated for, any type of cancer. |
| Parent | – | Behavioral: QuestionnairesParent(s) or caregiver(s) of children with cancer. |
| Medical Staff | – | Behavioral: QuestionnairesMedical staff (i.e., physicians, nurse practitioners) involved in the children's medical decision-making. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children between 6 and 17 years diagnosed with, and treated for, any type of cancer, their parent(s) or caregiver(s), and medical staff (i.e., physicians, nurse practitioners) involved in the children's medical decision-making.
Key inclusion criteria (7 listed)
- Children between 6 and 17 years diagnosed with, and treated for, any type of cancer
- Children enrolled in grades K through 12
- Children who have actively participated in community or private school during the 2006-2007 academic year
- Children who have experienced a period of absence from community or private school of at least two consecutive months as a result of medical treatment prior to school reintegration
- Children who have fully reintegrated as a full-time student within the past 1-3 years
Key exclusion criteria (3 listed)
- Children and/or parents diagnosed and/or identified as having mental retardation (IQ < 70) with concomitant adaptive behavior deficits or classified as having any type of Pervasive Developmental Disorder (PDD)
- Children and/or parents who speak a language other than English or Spanish
- Participant (e.g., parent or child) unwillingness to participate in any capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAlso: Survey5 Paper-and-Pencil Questionnaires: All participants will engage in a one-time completion of all measures. | Behavioural | Child, Medical Staff, Parent |
Primary outcome
Severity of Illness [using The Severity of Illness Scale (SOIS)]
Time frame: Completion of scale by medical staff, approximately 2-5 minutes
Quality of Life [using The Pediatric Quality of Life (PedsQL)]
Time frame: Questionnaire, approximately 45 minutes to one hour for parent or non-parent caregivers to complete their measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Askins, PhD, BA, MA principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Illness [using The Severity of Illness Scale (SOIS)] (time frame: Completion of scale by medical staff, approximately 2-5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2012.